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Purpose

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have had an established diagnosis of UC of ≥3 months in duration before baseline. - Have moderately to severely active UC as assessed by the UC disease activity score. - Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). - Are on a stable dose of certain oral UC medications (including corticosteroids). - Must meet contraception requirements.

Exclusion Criteria

  • Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past. - Have experienced a thrombotic event within 24 weeks before baseline. - Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases. - Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study. - Have a history of certain adenomas, dysplasia's, or malignancies.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eltrekibart + Placebo 		Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
  • Drug: Eltrekibart
    Administered
    Other names:
    • LY3041658
  • Drug: Mirikizumab
    Administered
    Other names:
    • LY3074828
  • Drug: Placebo
    Administered
Experimental
Mirikizumab + Placebo 		Participants will receive mirikizumab and placebo or mirikizumab.
  • Drug: Mirikizumab
    Administered
    Other names:
    • LY3074828
  • Drug: Placebo
    Administered
Experimental
Eltrekibart + Mirikizumab 		Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
  • Drug: Eltrekibart
    Administered
    Other names:
    • LY3041658
  • Drug: Mirikizumab
    Administered
    Other names:
    • LY3074828
Experimental
Placebo 		Participants will receive placebo or mirikizumab.
  • Drug: Mirikizumab
    Administered
    Other names:
    • LY3074828
  • Drug: Placebo
    Administered

Recruiting Locations

Applied Research Center of Arkansas
Little Rock, Arkansas 72205
Contact:
501-954-7822

Erick Alayo Medical Corp/Gastro SB Clinic
Chula Vista, California 91910
Contact:
619-513-3372

Southern California GI and Liver Centers (SCLC)
Coronado, California 92118
Contact:
619-522-0330

Valley View Research
Garden Grove, California 92845
Contact:
855-229-1665

Om Research, LLC
Lancaster, California 93534
Contact:
661-388-2239

United Medical Doctors
Los Alamitos, California 90720-3433
Contact:
562-430-4449

Clinnova Research
Orange, California 92868-4402
Contact:
949-889-0249

Prospective Research Innovations
Rancho Cucamonga, California 91730-4850
Contact:
707-940-7767

Clinical Trials Management Services, LLC
Thousand Oaks, California 91360
Contact:
1-805-906-7800

Om Research LLC
Victorville, California 92395
Contact:
661-388-2239

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907-6262
Contact:
719-362-2281

Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518-3602
Contact:
203-281-5161

Well Pharma Medical Research Corp.
Miami, Florida 33173
Contact:
305-665-4818

Orlando Health Digestive Health Institute
Orlando, Florida 32803-1248
Contact:
216-502-0981

Nodal Medical Center
Tampa, Florida 33607
Contact:
813-374-0568

Research Bay,Inc.
Tampa, Florida 33607
Contact:
813-304-1265

GCP Clinical Research, LLC
Tampa, Florida 33609
Contact:
813-240-9734

International Center for Research LLC
Tampa, Florida 33614
Contact:
813-930-8816

Avicenna Clinical Research - SW Gastroenterology
Oak Lawn, Illinois 60453-3754
Contact:
708-499-5678

Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan 49519
Contact:
616-328-5344

Ellipsis Research Group
Brooklyn, New York 11215
Contact:
347-422-0317

Smart Medical Research - Jackson Heights
Jackson Heights, New York 11372
Contact:
718-305-1900

Pioneer Clinical Research NY
New York, New York 10012-3645
Contact:
917-977-0900

Digestive Disease Medicine of Central New York
Utica, New York 13502
Contact:
315-624-7035

University of North Carolina
Chapel Hill, North Carolina 27599
Contact:
919-445-3880

GCGA Physicians, LLC dba / Gastro Health Research
Cincinnati, Ohio 45219
Contact:
513-872-4549

NexGen Research
Lima, Ohio 45801
Contact:
419-516-0954 Ext 105

Inquest Clinical Research
Baytown, Texas 77521
Contact:
281-428-8203

DHR Health Gastroenterology - Edinburg
Edinburg, Texas 78539
Contact:
956-362-2356

Baylor College of Medicine
Houston, Texas 77030
Contact:
713-798-7616

Intergrity Research
Houston, Texas 77043
Contact:
832-860-0720

Gastroenterology Research of San Antonio
San Antonio, Texas 78229
Contact:
210-615-3848

Tyler Research Institute
Tyler, Texas 75701
Contact:
903-630-6211

Care Access-Ogden
Ogden, Utah 84403
Contact:
801-614-0010

Advanced Research Institute - South Ogden
Ogden, Utah 84405
Contact:
801-409-2040

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Detailed Description

The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.